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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 135cm
Spectranetics Corporation
AB35SX060080135
In Commercial Distribution

  • 00813132023249 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060080135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 135cm
Spectranetics Corporation
AB35SX060040135
In Commercial Distribution

  • 00813132023232 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060040135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 135cm
Spectranetics Corporation
AB35SX050120135
In Commercial Distribution

  • 00813132023225 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050120135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 135cm
Spectranetics Corporation
AB35SX050080135
In Commercial Distribution

  • 00813132023218 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050080135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 135cm
Spectranetics Corporation
AB35SX050040135
In Commercial Distribution

  • 00813132023201 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050040135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 135cm
Spectranetics Corporation
AB35SX040120135
In Commercial Distribution

  • 00813132023195 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040120135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 135cm
Spectranetics Corporation
AB35SX040080135
In Commercial Distribution

  • 00813132023188 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040080135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 135cm
Spectranetics Corporation
AB35SX040040135
In Commercial Distribution

  • 00813132023171 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040040135

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX060120080
In Commercial Distribution

  • 00813132023164 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060120080

  • Peripheral angioplasty balloon catheter, drug-coated
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX060080080
In Commercial Distribution

  • 00813132023157 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060080080

  • Peripheral angioplasty balloon catheter, drug-coated
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